双抗深度报告(五):国内双抗企业及管线梳理.pdf

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1 / 18 | 2021 05 20 S0300520100001 010-64814022 ( 12 ) 2021-04-27 WHO 2021-05-10 2021-05-12 60 6 IBI-318 PD-1 PD-L1 IBI-302 C3 VEGF IBI-315 PD-1 HER2 IBI-319 PD-1 4-1BB IBI-322 PD-L1 CD47 IBI-323 PD-L1 LAG-3 IBI-318 IBI-302 IBI-318 PD-1 PD-L1 IgG1 PD-1 T PD-L1 PD-1 PD-L1 IBI-302 VEGF N VEGF VEGF VEGF C C3b C4b SHR-1701 PD-L1/TGF- T PD-L1 TGF- PD-L1/TGF- M7824 TGF- PD-(L)1/TGF- -3% 10% 23% 36% 49% 20-05 20-08 20-11 21-01 21-04 沪深300 医药生物 2 / 18 . 3 IBI-318 PD-1 PD-L1 . 3 IBI-302 VEGF C3 . 4 IBI-315 PD-1 HER2. 6 IBI-319 PD-1 4-1BB . 7 IBI-322 PD-L1 CD-47 . 8 IBI-323 PD-L1 LAG-3 . 9 :PD-L1 TGF- . 10 PD-(L)1 TGF- . 12 M7824 . 12 PM8001 . 14 JS201PD-1 TGF-. 15 . 16 1 . 3 2 PD-1/PD-L1 . 3 3 IBI-318 . 4 4 AMD . 5 5 IBI-302 . 5 6 PENTAMBODY . 6 7 4-1BB PD-(L)1 . 7 8 CD47-SIRP . 8 9 CD47 . 9 10 FGL1-LAG3 . 10 11 TGF- .11 12 IBI-302 . 12 13 M7824 . 12 14 M7824 2018 ASCO . 13 15 M7824 2020 CSCO . 14 16 PM8001 . 15 17 JS201 . 16 3 / 18 2011 IBI-318 PD-1 PD-L1 IBI-302 C3 VEGF IBI-315 PD-1HER2 IBI-319 PD-1 4-1BB IBI-322 PD-L1 CD47 IBI-323 PD-L1 LAG-3 IBI-318 IBI-302 1 NDA IBI-318 PD-1 PD-L1 IBI-302 C3 VEGF IBI-315 PD-1 HER2 IBI-319 PD-1 4-1BB IBI-322 PD-L1 CD-47 IBI-323 PD-L1 LAG-3 IBI-318 PD-1 PD-L1 PD-1 PD-L1 MSI TMB PD-1 20% -30% PD-1 PD-1 PD-1 PD-1/PD-L1 IBI-318 IBI-318 PD-1 PD-L1 IgG1 PD-1 T PD-L1 PD-1 PD-L1 2 PD-1/PD-L1 4 / 18 2019 2 IBI-318 NMPA 2020 IBI-318 1a 2020 1b/ IBI-318 NK/T 3 IBI-318 IBI-318 IBI318+ Ib 2020-11-26 IBI318+cTACE Ib 2020-11-17 IBI318 Ib/II 2020-10-30 NK/T IBI318 II 2020-10-15 IBI318 I 2019-03-01 1 2020 6 ASCO IBI-318 a a IBI-318 2020 1 10 a 15 0.3mg 1mg 3mg 10mg 30mg 100mg 300mg 3 600mg 2 12 1 9 10mg IBI-318 3 11 TRAE TRAE 20% G1/2 20% G1/2 3 TRAE 300mg 1 IBI-302 VEGF C3 AMD nAMD AMD AMD 15% 20% 65 AMD AMD VEGF AMD AMD AMD VEGF nAMD 4 8 VEGF 2/3 7 VEGF VEGF 5 / 18 4 AMD Nature Reviews IBI-302 VEGF N VEGF VEGF VEGF C C3b C4b VEGF 2011 VEGF C3 IBI-302 AMD 2021 4 29 IBI302 wAMD 5 IBI-302 IBI-302 IBI-302 II 2021-04-12 IBI-302 Ib 2020-04-26 IBI-302 I 2019-01-23 6 / 18 1 nAMD 2020 11 IBI302 31 IBI302 IBI302 28 31 6 141.2 6 IBI-315 PD-1 HER2 2017 PD-1/HER2 IBI-315 IBI-315 PD-1/HER2 IgG1 HER2 PD-1/PD-L1 PD-1 T HER2 PENTAMBODY PENTAMBODY IgG 6 PENTAMBODY Hanmi 7 / 18 2019 11 IBI315 IBI315 CIBI315A101 IBI315 HER2 RP2D 2021 IBI-315 1a 2021 IBI-315 1b IBI-319 PD-1 4-1BB IBI-319 PD-1/4-1BB 4-1BB T 4-1BB T CTL NK 4-1BB 4-1BB BMS Urelumab BMS-663513 4-1BB IBI-319 T PD-1 4-1BB PD-1/PD-L1 4-1BB 4-1BB 2020 11 12 IBI-319 2021 1 8 IBI-319 7 4-1BB PD-(L)1 Numab 8 / 18 IBI-322 PD-L1 CD-47 CD47 SIRP N Dont eat me CD47 CD47-SIRP 8 CD47-SIRP SIRP CD47 Immune Checkpoint Blockade in Anticancer Therapy CD47 1 CD47 CRT Ca2+ CRT CRT CD47 CD47 CD47 AE 2 CD47 CD47 CD8+T NK ADCC CDC 9 / 18 9 CD47 Trillium Therapeutics IBI-322 CD47/PD-L1 CD47 SIRP PD-L1 PD-1 IBI-322 SIRP CD47 CD47 CD47 IBI322 PD-1 PD-L1 CD4+T PD-L1 CD47 PD-L1 IBI-322 2020 1 IBI-322 NMPA FDA IND 2020 8 IBI-322 a/ b IBI-322 IBI-323 PD-L1 LAG-3 LAG-3 LAG-3 -3 Lymphocyte Activation Gene-3 CD4 T NK B LAG3 MHC T 2018 FGL1 LAG-3 FGL1 LAG-3 T 10 / 18 10 FGL1-LAG3 Fibrinogen-like Protein 1 is a Major Immune Inhibitory Ligand of LAG-3 IBI-323 LAG-3 PD-L1 PD-L1 LAG-3 T T LAG-3 T T 2020 10 IBI-323 :PD-L1 TGF- - Transforming Growth Factor- TGF- TGF- TGF- TGF- TGF- TGF- TGF- TGF- T Th1 Treg TGF- Smad TGF- 11 / 18 11 TGF- Tranforming Growth Factor- Signaling in Immunity and Cancer SHR-1701 PD-L1/TGF- T PD-1 TGF- 2020 9 SHR-1701 / b/ SHR-1701 NMPA 2020 11 DONG-A ST CO.,LTD. SHR-1701 12 / 18 12 IBI-302 SHR-1701 SHR-1701+ II 2021-05-11 SHR-1701+ +XELOX II/III 2021-04-22 SHR-1701+ I /II 2021-04-21 SHR-1701+ II 2021-01-13 SHR-1701 II 2020-12-08 SHR-1701+ I/II 2020-11-25 SHR-1701+ + Ib/II 2020-11-09 SHR-1701 II 2020-10-10 SHR-1701 I 2020-02-20 SHR-1701 I 2018-12-18 SHR-1701 I 2018-10-09 PD-(L)1 TGF- M7824 M7824 Bintrafusp alfa IgG1 177kDa N PD-L1 C TGF- TGF- PD-L1 TGF- M7824 PD-L1 FDA Avelumab TGF TGF- IgG1 TGF- TGF- 13 M7824 13 / 18 2018 ASCO M7824 NSCLC 71.4% ORR PD-L1 M7824 M7824 GSK 2019 2 GSK 42 M7824 1 NSCLC 2018 ASCO M7824 80 PD-1 NSCLC 40 500mg 40 1200mg 1200mg 40 M7824 NSCLC ORR 27.5% PD-L1 1% ORR 40.7% 11/27 PD-L1 80% ORR 71.4% 5/7 PD-1 20% 19% 12.5% 4 3 TGF- 14 M7824 2018 ASCO 2018 ASCO 2 NSCLC 2020 CSCO M7824 80 NSCLC 72.5% PD-L1 1 1 500mg 1200mg 1200mg ITT OS 17.1 PD-L1 1% OS 12.2 PD-L1 OS 21.7 PD-1 OS ITT ORR 23.8% DOR 15.3 1200mg ORR 27.5% DOR 18 M7824 21.3% 18% 12.5% 3 28.8 14 / 18 15 M7824 2020 CSCO 2020 CSCO 2021 M7824 2021 1 M7824 M7824 K NINTRPID Lung 037 PFS 2021 3 16 M7824 INTRPID BTC 047 INTRPID BTC 047 159 9 M7824 ORR 10.1% M7824 TGF- 1 TGF- TGF- 2 TGF- CTC TGF- PM8001 2018 7 PM8001 PD-L1 TGF- PM8002 PD-L1 VEGF PM8001 M7824 N PD-L1 C 15 / 18 TGF- TGF- PD-L1 TGF- PM8001 110Kda TGF- 1 TGF- 3 TGF- 2 2020 3 PM8001 2020 8 14 PM8001 1/2a 1 37 2a 210 1 2a PM8001 16 PM8001 JS201 PD-1 TGF- JS201 PD-1 TGF- 2021 5 6 JS201 NMPA JS201 PD-1/PD-L1 TGF- NOAEL 100mg/kg / JS201 JS201 PD-1 TGF TGF- IgG1 TGF- TGF- 16 / 18 17 JS201 17 / 18 2016 S0300520100001 10485001 12 300 10% 5%10% -5%5% -5% 12 300 5% -5% 5% 5 18 / 18 60 21-23 6 2 1088 20
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